Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Date Added
February 7th, 2022
PRO Number
Pro00118666
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with unfavorable intermediate risk prostate cancer, a low gene risk score and plan to receive radiation therapy with hormone therapy. The purpose of the study is to answer to find out if radiation therapy alone is as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy. The study is also going to determine if adding another new hormone therapy drug to the usual combination of radiation and hormone therapy increase the length of time without the prostate cancer spreading compared to the usual treatment.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Date Added
February 7th, 2022
PRO Number
Pro00118666
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with unfavorable intermediate risk prostate cancer, a low gene risk score and plan to receive radiation therapy with hormone therapy. The purpose of the study is to answer to find out if radiation therapy alone is as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy. The study is also going to determine if adding another new hormone therapy drug to the usual combination of radiation and hormone therapy increase the length of time without the prostate cancer spreading compared to the usual treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers

Date Added
February 1st, 2022
PRO Number
Pro00115767
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for participants with tumors from pediatric cancers and genomic/molecular testing was done as part of standard of care treatment. This is an observational study; therefore, only information about the disease and medical treatment will be collected and participants will not receive any treatments or additional medications. The sponsor, Beat Childhood Cancer, will collect and store personal health information and molecular/genomic test results, tissue samples, and bodily fluids (examples: additional tube(s) of blood, urine, bone marrow or cerebral spinal fluid) that are left over after testing or treatment is completed in a data registry and a specimen bank, and make these available for future research. Database personnel will continue to collect and store participant information from future visits, as long as they do not withdraw from participation in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma

Date Added
February 1st, 2022
PRO Number
Pro00113673
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with Medulloblastoma. The purpose of this study is to test the effectiveness of using an investigational agent called DFMO for Medulloblastoma. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to either keep participants tumor in remission or if they have active tumor, for their tumor to respond to the treatment and will also look at the safety and tolerability of DFMO. After this first day participants will be seen in clinic once every 30 days for the first 6 months of the study, after that they will be seen once every 90 days for the remainder of the study. These visits will last about 2 hours.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adult Subjects with Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)

Date Added
January 26th, 2022
PRO Number
Pro00115910
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

The purpose of this study is to learn more about the safety and effectiveness of the drug omadacyline for people with Nontuberculous Mycobacterial (NTM) pulmonary disease, caused by a type of mycobacteria called Mycobacterium abscessus complex (MABc). Participants will be randomly assigned to receive either omadacycline or placebo, with a 60% chance of being treated with omadacycline and a 40% chance of being treated with placebo. About 75 men and women with NTM lung infection caused by MABc, ages 18 and up, will be in this study, with an estimated 4 participants being enrolled from the MUSC site. Participants will be in this study for approximately 5 months in total, beginning with the Screening visit and continuing until their last study visit.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Accuracy and Patient Acceptability of Flash Glucose Monitoring in Women with Diabetes in Pregnancy

Date Added
January 18th, 2022
PRO Number
Pro00117649
Researcher
Matthew Finneran

List of Studies


Keywords
Obstetrics and Gynecology
Summary

This study will access the accuracy of the FreeStyle Libre system when compared to a finger stick blood glucose test. We will also look at a patients satisfaction with the Freestyle Libre system.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

BOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Date Added
January 12th, 2022
PRO Number
Pro00115726
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Date Added
January 11th, 2022
PRO Number
Pro00117676
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients who have cancer and are experiencing loss of weight and appetite. The study wants to find out if this taking olanzapine for four weeks will increase your appetite as compared to megestrol acetate. The study is looking to see if that approach is better or worse than the usual approach for your loss of appetite and weight. The usual approach is defined as care most people get for loss of appetite.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
Broe@tidelandshealth.org

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Date Added
January 11th, 2022
PRO Number
Pro00117607
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome). This study is testing an "investigational" (not yet FDA approved) study drug called Sea-CD70. This study will find out if the drug is safe and tolerable, and find out the maximum tolerated dose (highest dose of a drug or treatment that does not cause unacceptable side effects) or recommended dose for the next phase of clinical study. The subject will be given the study drug in 28 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, ECG (electrocardiogram), or a bone marrow exam. The subject may remain in the study for up to approximately 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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